NERLYNX

This brand name is authorized in United States. It is also authorized in Austria, Canada, Croatia, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Singapore, UK.

Active ingredients

The drug NERLYNX contains one active pharmaceutical ingredient (API):

1	Neratinib UNII 9RM7XY23ZS - NERATINIB MALEATE ANHYDROUS
	Neratinib is an irreversible pan–erythroblastic leukaemia viral oncogene homolog (ERBB) tyrosine kinase inhibitor (TKI) that blocks mitogenic growth factor signal transduction through covalent, high affinity binding to the ATP binding site of 3 epidermal growth factor receptors (EGFRs): EGFR (encoded by ERBB1), HER2 (encoded by ERBB2), and HER4 (encoded by ERBB4) or their active heterodimers with HER3 (encoded by ERBB3). This results in sustained inhibition of these growth promoting pathways with HER2-amplified or over-expressed, or HER2-mutant breast cancers.
	Read more about Neratinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
NERLYNX Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)
NERLYNX Film-coated tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC Group		Classification
L01EH02		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EH Human epidermal growth factor receptor 2 (HER2) tyrosine kinase inhibitors
Discover more medicines within L01EH02

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
CA	Health Products and Food Branch	02490536
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	5345-MEE-0720
EE	Ravimiamet	1778991
FI	Lääkealan turvallisuus- ja kehittämiskeskus	181310
FR	Base de données publique des médicaments	69627592
GB	Medicines & Healthcare Products Regulatory Agency	378569
HK	Department of Health Drug Office	66416
IL	מִשְׂרַד הַבְּרִיאוּת	8305
IT	Agenzia del Farmaco	046987018
LT	Valstybinė vaistų kontrolės tarnyba	1086200
NL	Z-Index G-Standaard, PRK	202762
NZ	Medicines and Medical Devices Safety Authority	20851
PL	Rejestru Produktów Leczniczych	100410717
SG	Health Sciences Authority	15861P
US	FDA, National Drug Code	70437-240